background image

Glossary of Terms, Acronyms, and Definitions 

LS 06311-002US Rev A

 

 

viii 

 

GENERAL WARNINGS AND CAUTIONS 

 

REFER TO SONATA SYSTEM INSTRUCTIONS FOR USE FOR COMPLETE WARNINGS AND 
CAUTIONS 

 

COMPONENTS ARE NOT OPERATOR SERVICEABLE  
Do not attempt to remove protective covers on any components of the Sonata System. Parts within the 
protective covers of any component are not serviceable by the operator. 

 

DO NOT REMOVE COVERS 
DO NOT attempt to remove protective covers on any components of the Sonata System. None of the parts 
within the protective covers of any component are operator serviceable. As outlined in Technical Manual 
Chapter 1, operator serviceable parts may be accessed without removal of the protective covers. The 
protective covers prevent access to potential electrical and mechanical hazards. Touching any components 
behind access covers may create a pathway for current leakage, presenting an electrical shock hazard to 
the operator or to the patient. If the system function is in question, call a Gynesonics representative for 
service 

 

USE GROUNDED CONNECTIONS 
Use only grounded electrical connections. Connecting the Sonata System to a power source that is not 
equipped with a protective earth contact creates a shock hazard for the operator or may compromise the 
reliability of the system and other equipment attached to the same circuit. Interrupting the protective 
conductor inside or outside the device, or interrupting the protective earth terminal can, create a shock 
hazard for the operator. To achieve the enhanced grounding reliability of the hospital-grade plug provided, 

use an outlet marked “hospital only” or “hospital grade”, if available.

 

 

 

SALE AND USE 
Federal law restricts this device to sale by or on the order of a physician. 

 

POWER CORDS AND EXTENSION CORDS  
Use only approved line cords provided by Gynesonics. DO NOT use additional multiple portable socket-
outlet strips or extension cords 

 

SMART TABLET CANNOT BE USED AS COMPUTER.  
The SMART Tablet resembles a tablet computer, but DO NOT attempt to use it as one. Actions to use it as 
a tablet computer may damage the system and expose it to risks such as attacks by viruses. These actions 
include installing or updating software, connecting the system to a network, or attempting to access the 
native operating system 

 

COMPONENT OPENINGS 
DO NOT obstruct any openings on Sonata System components, such as cooling vents for the SMART Tablet 
and for the RF Generator. Doing so may result in compromised product life or cause overheating of 
equipment 

 

BATTERY  
DO NOT attempt to remove or use the battery inside the SMART Tablet. 

Содержание Sonata System

Страница 1: ...Sonata System Service Manual For Sonata System 2 1 and Sonata System 2 2 SONATA2 110 with software SW 002 Manual Catalog REF 011US LS 06311 002US Rev A January 2021...

Страница 2: ...use of this device or concerning any safety or operating instructions described in this manual or for additional copies of this manual please contact your local Gynesonics Representative or the servic...

Страница 3: ...m Overview 11 1 5 Standards 13 1 6 Reference Documents 14 1 7 Personnel Qualification and Service Documentation 14 1 8 Tools Recommended for Service 15 Chapter 2 Electrical Safety Tests 16 2 1 Visual...

Страница 4: ...hical symbols for use on equipment Catalogue number Indicates the manufacturer s catalogue number so that the medical device can be identified ISO 15223 1 5 1 6 Medical devices Symbols to be used with...

Страница 5: ...the electrical equipment that is not ME EQUIPMENT have been dversely affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM e electrical equipment that is not ME EQUIPMENT have been determi...

Страница 6: ...ded by Enclosures Fuse To identify fuse boxes or their location Accompanied by the type and full rating of the fuse IEC TR 60878 5016 Graphical symbols for electrical equipment in medical practice IEC...

Страница 7: ...0 W001 Graphical symbols Safety colours and safety signs Registered safety signs ISO 7000 2621 Graphical symbols for use on equipment TUV Mark Indicates that the product was tested and met the certifi...

Страница 8: ...L TITLE EXPLANATORY TEXT STANDARD REFERENCE STANDARD TITLE Prescription Only Requires a prescription in the United States 21 CFR 801 15 c 1 i F Labeling Medical devices prominence of required label st...

Страница 9: ...LUG Part integral with or intended to be attached to a POWER SUPPLY CORD of electrical equipment to be inserted into a mains socket outlet IEC 60601 1 3 50 MSO MULTIPLE SOCKET OUTLET One or more socke...

Страница 10: ...earth contact creates a shock hazard for the operator or may compromise the reliability of the system and other equipment attached to the same circuit Interrupting the protective conductor inside or o...

Страница 11: ...ore attempting to check power cord connections to system SYSTEM INPUTS AND OUTPUTS The Sonata System has input output I O ports that are only intended for particular functions with regards to external...

Страница 12: ...ssociated with heavy menstrual bleeding 1 3 Room Requirements The Sonata System is intended for use in locations in which minimally invasive procedures are performed The Sonata System is suitable for...

Страница 13: ...e Sonata Graphical Guidance Software GGS integrates ablation planning targeting and ablation of fibroids The SMART Guide displays a real time graphic overlay on the live ultrasound image for targeting...

Страница 14: ...ns and Controls on the RF Generator CAUTIONS POWER CORDS AND EXTENSION CORDS Use only approved line cords provided by Gynesonics DO NOT use additional multiple portable socket outlet strips or extensi...

Страница 15: ...ectrical equipment and medical electrical systems EN IEC 60601 2 2 Medical Electrical Equipment Particular requirements for the basic safety and essential performance of high frequency surgical equipm...

Страница 16: ...ocumentation The procedures in this manual are intended to be performed by personnel who are trained in the maintenance of electrical equipment such as typically found in hospital biomedical engineeri...

Страница 17: ...ore of the requirements in the standards outlined in Section 1 5 Examples of appropriate instruments include DALE 601 Electrical Safety Analyzer Fluke ESA620 615 614 612 Electrical Safety Analyzer The...

Страница 18: ...esting Item Instructions and Test Conditions Standards Clause Acceptance Criteria Visual Inspection of Physical Integrity 2 1 IEC 62353 Clause 5 2 NFPA 99 2018 10 3 1 Any condition that appears to aff...

Страница 19: ...sing and enclosure of the RF Generator and Tablet Cabling including power cords USB and Sync cables Look for defects such as cuts and wear User documentation or IFU The documentation is accessible and...

Страница 20: ...LS 06311 002US Rev A 18 Figure 1 1 Connections for the Ground Resistance Test Figure 2 2 The measurement of the Ground Resistance Ref IEC 62353 Figure 1 Figure 2 3 The measurement of the insulation r...

Страница 21: ...are also tested and meet acceptance criteria prior to testing touch current Personnel safety may be compromised if the grounding conductor is not intact and the leakage or touch current is high Measur...

Страница 22: ...Chapter 2 Electrical Safety Tests LS 06311 002US Rev A 20 Figure 2 5 Touch Current Test Connections PE Post for Leakage Tests...

Страница 23: ...e ACCY 014 Conditions of test include Power plug connected normally System powered on Ground switch CLOSED NC limit 100 A and separately with ground switch OPEN SFC limit 500 A Leakage current measure...

Страница 24: ...ssue temperature of 105 C as measured by thermocouples in the Radiofrequency Ablation RFA Handpiece 3 Temperature variation variation between signal to signal when measuring the same reference medium...

Страница 25: ...nimum and maximum of all 4 temperature channels read by the RF Generator are within 4 C Click the message column to sort data and scroll down to find Hand Piece Connected TC s Figure 2 7 If the maximu...

Страница 26: ...r 3 Troubleshooting Sonata System provide comprehensive messages for the system and device errors Please refer the error code list in Chapter 7 of the Sonata System Instructions for Use Anytime an abn...

Страница 27: ...ta System 2 1 or Sonata System 2 2 hardware upgrade should be performed by a Gynesonics service representative After the upgrade the system visual inspections and safety tests should be performed and...

Страница 28: ...tic uterine fibroids including those associated with heavy menstrual bleeding To learn more visit www gynesonics com sonata system Gynesonics Sonata and the logo are trademarks and registered trademar...

Отзывы: